scholarly journals A comparative study between ranibizumab and its first biosimilar razumab in terms of efficacy and safety in DME, RVO and wet AMD associated with CNVM

2021 ◽  
Vol 7 (2) ◽  
pp. 346-351
Author(s):  
Preethi B ◽  
Shilpa G ◽  
Dhwani Anil Shah ◽  
Praveen R Murthy

To compare safety and efficacy of intravitreal therapy between anti vascular endothelial growth factor (Anti-VEGF) Ranibizumab and biosimilar Razumab in diabetic macular oedema (DME), wet age related macular degeneration (AMD) with choroidal neovascular membrane (CNVM) and retinal vein occlusion (RVO). Prospective comparative study involved 60 eyes of 56 adults, randomized into 2 groups from September 2016 to November 2017. Group 1 (n=30) received Ranibizumab (0.5mg in 0.05ml) and group 2(n=30) Razumab (0.5mg in 0.05ml). Initial loading dose of one injection given to all subjects and a pro re nata schedule followed thereafter. Patients received maximum of 3 injections and were followed up to 12 weeks. Best corrected visual acuity (BCVA) and central foveal thickness (CFT) were considered for the primary outcome and adverse drug reactions (ADR) was considered in the secondary outcome. A p value of less than 0.05 was considered statistically significant. The 12-week mean BCVA in group 1 was 0.39 (+-0.24); and in group 2 was 0.53 (+-0.37), which had improved significantly from baseline (group 1 p= 0.007, group 2 p <0.001). Inter group comparison was statistically insignificant (p=0.249). The 12 weeks mean CFT in group 1 was 308 (+-107.26) ; and group 2 was 307.60 (+- 87.15), which had improved significantly from baseline in both groups (p <0.001). Inter group difference was statistically insignificant (p=0.544). One patient in group 2 experienced an ADR (p=0.305). In this study both Ranibizumab and Razumab were safe and efficacious.

2016 ◽  
Vol 22 (4) ◽  
pp. 196-204
Author(s):  
Rasa Liutkevičienė ◽  
Rasa Čiumbaraitė ◽  
Mantas Banevičius

Background. It has been suggested that contrast sensitivity can provide valuable information about visual function in addition to visual acuity assessment. Some patients retain relatively good visual acuity, yet complain of poor vision. In these patients, other tests of visual function such as contrast sensitivity should be evaluated. Methods. We examined patients with early mild stage age-related macular degeneration (group 1), and early intermediate stage age-related macular degeneration (group 2). Digital analysis methodology was used for retina drusen localisation and its diameter measurement. Functional acuity contrast sensitivity tests (FACT) were performed using a Ginsburg Box, VSCR-CST-6500. Results. The  nighttime results without glare in group  2 were worse at 1.5, 3, 6 and 18 cycles per degree of the visual angle, the daytime results without glare were worse at 3 and 6 cycles per degree. The nighttime results with glare were worse at 1.5, 3, 6 and 18 cycles per degree, and the daytime results with glare were worse at 1.5 and 3 cycles per degree. Results after adjusting for age and visual acuity to 1.0 in the  group 1  patients were better compared to the  group 2 patients and the p value was 0.0005. Conclusions. The  test results in patients with early intermediate age-related macular degeneration, in comparison to early mild age-related macular degeneration, showed a  significant decrease mostly in the nighttime either with or without glare in high and medium spatial frequencies (cycles/degree). After adjusting for age and visual acuity the FACT results were even worse in early intermediate AMD patients.


2020 ◽  
Vol 9 (1) ◽  
pp. OT05-OT08
Author(s):  
Jyoti Dhaka ◽  
Ashok Kumar Grover

Background: To compare the surgical outcome of unilateral silicone sling with bilateral fascia latafrontalis suspension surgery for severe unilateral congenital ptosis.Subjects and Methods:This prospective, interventional and comparative study examined 30 patients of severe unilateral congenital ptosis. 30 patients were divided in to 2 groups, group 1 included 15 patients who underwent unilateral silicone sling frontalis suspension surgery and group 2 included 15 patients who underwent contralateral levator excision with bilateral fascia latafrontalis sling surgery.Results:Mean improvement in MRD1 after surgery in group 1 who underwent unilateral silicone sling surgery was 3.9+1.18 mm and in group 2 who underwent bilateral fascia lata it was 4.9+0.89 mm (p value 0.0001). Excellent results (difference of lid height <1 mm) were seen in 93.3% patients who underwent bilateral fascia latafrontalis sling while in 73.3% patients of unilateral silicone sling. All patients who underwent bilateral fascia lata showed excellent lid crease (symmetric without obliteration) and 80% of the patients who underwent unilateral silicone sling surgery (p value 0.032).Conclusion: Functional and cosmetic outcomes regarding MRD1, symmetry of lid height, lid crease were noted better in group 2 patients who underwent contralateral levator excision with bilateral fascia latafrontalis suspension surgery as compared to group 1 patients who underwent unilateral silicone sling surgery.


2019 ◽  
Author(s):  
Ahmed Abdelwahab Saad ◽  
Daniela Vaideanu-Collins ◽  
Lyudmila Kishikova ◽  
Marco Isac ◽  
Dina Hamada ◽  
...  

Abstract Background To compare the outcome of vitrectomy, subretinal tissue plasminogen activator (TPA), and gas with and without subretinal air versus Intravitreal TPA and gas in the treatment of sub macular haemorrhage (SMH) due to Neovascular age related macular degeneration Methods We analysed the notes of 29 cases presented with SMH in the period between 01/2016 and 09/2018 in James Cook University Hospital. Presenting visual acuity (BCVA), size and location of SMH, Procedure done, final BCVA at 6 months and any surgical complications were recorded. 11 Cases (Group 1) received intravitreal TPA (50ug in 0.1 ML), 0.3 ml of pure SF6. 18 cases (Group 2) received 23 G Pars Plana vitrectomy, Subretinal TPA injection (25ug in 0.1 ml), and 20% SF6 gas filling. Group 2 was further divided into 2A (10 patients) who received only subretinal TPA and group 2B (8 patients) who received additional 0.1 ml subretinal air.Results The mean BCVA at presentation was 0.0068 in group 1 and 0.0067 in group 2 (p= 0.8734). The mean postoperative BCVA at six months was 0.31 in group 1 and 0.58 in group 2 (p=0.0015). Subgroup analysis of group 2 didn’t show statistically significant difference in outcome when adding subretinal air to the vitrectomy procedure (p=0.7009).Conclusion Vitrectomy, gas and subretinal TPA has more successful displacement rate and better visual outcome than Intravitreal TPA & Gas alone in treating SMH involving the fovea in AMD. Additional subretinal air doesn't seem to improve the outcome in cases having vitrectcomy.


2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Young-Woo Suh ◽  
Ji Sung Lee ◽  
Hwan Heo ◽  
Shin Hae Park ◽  
Seung-Hyun Kim ◽  
...  

Purpose. To investigate the association between vision improvement with refractive correction in the visually impaired eyes and the prevalence of ocular comorbidities in the South Korean population. Materials and Methods. The data of 24,620 individuals in the Korea National Health and Nutrition Examination Survey (KNHANES 2009–2011) were reviewed. Visual impairment was defined as a presenting visual acuity < 20/60. The participants with visual impairment in at least one eye were divided into 3 groups according to the best-corrected visual acuity (group 1: <20/30, group 2: ≥20/30 but <20/25, and group 3: ≥20/25). The prevalence of ocular comorbidities was estimated and compared between the three groups. Results. Visual impairment in at least one eye was found in 3031 individuals. Groups 1, 2, and 3 comprised 23.5%, 22.2%, and 54.3% of these visually impaired eyes, respectively. The prevalence of cataract, diabetic retinopathy, age-related macular degeneration, corneal opacity, blepharoptosis, and pterygium was similar to or even higher in group 2 compared to group 1. The prevalence of glaucoma and age-related macular degeneration was 5.40% and 11.39%, respectively, in group 2 and 3.31% and 3.76%, respectively, in group 3. Conclusions. Appropriate ophthalmologic examination is necessary even if people exhibit vision improvement after optical correction.


2020 ◽  
Author(s):  
Esra Vural ◽  
Leyla Hazar ◽  
Cigdem Karakukçu ◽  
M. Erkam Arslan ◽  
M. Raşit Sirem ◽  
...  

Purpose: To investigate the value of serum apelin-13 levels in age-related macular degeneration patients. Methods: Patients with dry-type AMD, treatment-naive neovascular-type AMD and the healthy control group were included in this study. Patients diagnoses were confirmed with detailed fundus examination, optical cohorence tomography and fundus flourescein angiography findings. Central foveal thickness and subfoveal choroidal thickness were evaluated. Both serum apelin-13 and vascular endothelial growth factor (VEGF) levels were measured by competitive-enzyme-linked immunosorbent assay (ELISA) principle. Results: A total of 84 patients, including 24 patients in the dry-type AMD group (group 1), 27 patients in the neovascular-type AMD (group 2) group and 33 in the control group (group 3) were included in the study. Mean BCVA were 76±4,5, 48,4±16,3, 83,4±3,09 ETDRS letters in groups 1, 2 and 3, respectively. Values of serum VEGF were 44.11±26.14 pg/mL, 56.53±53.77 pg/mL and 61.47±41.62 pg/mL in groups 1, 2 and 3, respectively (p=0.553, p=0.286, p=0.896, respectively). Values of serum apelin-13 were 586.47±167.56 pg/mL, 622.18±324.52 pg/mL, 379. 31±171.96 pg/mL in groups 1, 2 and 3, respectively (p=0.847, p=0.04, p≤0.001, respectively). There was a negative correlation between the value of serum apelin and visual acuity and choroid thickness. Conclusion: Serum apelin-13 were higher in both dry-type AMD patients and neovascular AMD patients compared to the control group. Further studies are needed.


2021 ◽  
Vol 28 (01) ◽  
pp. 125-130
Author(s):  
Tahir Hussain Khan ◽  
Ashfaq Hussain Rana ◽  
Sohail A. Malik

Objective: To compare the results after tympanoplasty between post-aural and per-meatal approach. Study Design: Comparative study. Setting: Social Security Landhi Hospital, Karachi. Al-Tibri Medical College & Hospital (Isra University Karachi Campus), old thana Malir, Karachi. Period: July 2017 till June 2018. Material & Methods: In this study, 76 Patients of both genders with dry tympanic membrane perforations were included. They were aged between 18 to 40 years. Period of research was one year, study was started since July 2017 till June 2018. Patients were distributed into two groups, group-1 and group-2. 38 patients were included in every group. In group-1, post-aural approach tympanoplasty was done. In group-2, per-meatal approach tympanoplasty was performed. Observed results of both procedures after 1st post-operated day, after 1st post-operated week, after 1st month and after 2nd month post operatively. Variables were intensity of pain, bleeding, PTA (Ac, BC and AB-gap measured by tympanometer) and duration (time period) of surgical procedure. Result: In group-1(post-aural approach tympanoplasty), out of 38 patients, 36 patients had intact grafted tympanic membrane while in group-2 (per-meatal approach tympanoplasty), 37 patients had intact grafted tympanic membrane and 1 patient had residual perforation. Smaller amount of bleeding was noted during surgery and post-operative in group-2, in comparison with group-1. All the dressing gauze were dry in per-meatal approach tympanoplasty group (group-2). Mean time period of surgery was less in per-meatal tympanoplasty (group-2) 65.1 + 3.7 mins and mean time period of post-aural tympanoplasty (group-1) was 82.0 + 5.6 mins. P value was found to be significant i.e. < 0.001. Consumed time period of surgery was also decreased in per-meatal tympanoplasty (group-2). After tympanoplasty, hearing status was also enhanced on PTA in both groups. Post- operatively, it was observed that AB gap was reduced in both groups. On 1st post -operative day, Weber test was done, vibrating sound was heard (lateralized) in post-operated ears which ensured the safety of inner ear apparatus. Conclusion: Results of post-aural and per-meatal tympanoplasty were approximately same but per-meatal approach tympanoplasty is superior as it took shorter amount of time period, minimum post- operative pain and post- operative bleeding.


2019 ◽  
Vol 8 (3) ◽  
pp. 66-71
Author(s):  
A. A. Stadnikov ◽  
N. S. Khodzhaev ◽  
A. D. Chuprov ◽  
S. M. Kim

The aim of the study was to evaluate regularities of morphological and functional reorganization of the rabbit retina in the experimental simulation of age-related macular degeneration (AMD) and the use of melatonin.Material and methods. The study included 21 sexually mature male rabbits (42 eyes) weighed 2800– 3300 g, chinchilla breed. All the animals included in the study were divided into 3 groups: group 1 (experimental) (n=9), group 2 (control) included animals that were simulated AMD (n=9), and group 3 (intact) (n=3). Surgical interventions were performed in sterile conditions using an Opton operating microscope (Germany). Massage of the retina was performed under visual control through fixed caliber ports with a 25 G silicone-tip cannula at 10 and 2 hours in 4 mm from the limb, retreating from the optic nerve disk at a distance equal its one diameter, until the pigment epithelium was destroyed (dispersion). The size of the injury was 3 mm (RF Patent for the invention No. 2480844, 2011). Group 1 (experimental) was orally administered a suspended solution of the drug “Melaxen” (the active substance is melatonin), dosage 10 ml/kg daily once a day from 21.00 to 22.00 h for 3 months. Animals of group 2 did not receive treatment. Experimental animals were removed from the experiment on the 30th, 60th and 90th days. A histological and immunocytochemical study of the retina of experimental, control, and intact (without AMD simulation) animals was performed, including two-stage reactions to identify proteins p-53 and bcl-2.Results. Experimental histological studies allowed us to obtain a model of AMD, which corresponded to the morphological manifestations of the exudative form of chorioretinal dystrophy and destruction with a primary lesion of the choriocapillaris layer of the uveal tract. The use of melatonin for therapeutic purposes resulted in the resistant adaptation of pigment epithelium and retina gliocytes, reduction of pigment dystrophy and hemorrhage, destruction, reduction of apoptotic dominant and plexiform layers of the retina.


Author(s):  
Turgut Burak ◽  
Mercan Kadir ◽  
Demir Nesrin ◽  
Ilhan Nevin ◽  
Çatak Onur

Purpose: To evaluate the levels of salusin-beta (β-SAL) in the serum in patients with age-related macular degeneration (ARMD). Methods: Our study was designed as a controlled comparative clinical study. The β-SAL levels in serums of age and sex-matched 20 healthy volunteers as controls (Group 1), 20 patients with dry-age related macular degeneration (d-ARMD) (Group 2) and 20 patients with wet-age related macular degeneration (w-ARMD) (Group 3) were measured with the enzyme-linked immunosorbent assay (ELISA) method. Results: In our study, it was found that age and gender didn’t show a statistically significant difference among the study groups (p > 0. 05). The mean serum β-SAL levels in Group 1, Group 2 and Group 3 were 1372,17 ± 1126.69 pg/mL; 1423,71 ± 1196.84 pg/mL and 940,57 ± 1092.05 pg/mL, respectively. Although the meanβ-SAL levels in w-ARMD seem numerically lower than both the control and d-ARMD groups, this difference among the study groups was not statistically significant (p > 0.05). Conclusion: Our study suggests that β-SAL levels in the patients with ARMD and healthy controls were not different than each other. Further studies with large numbers may reveal possible relationships between β-SAL and ARMD.


Author(s):  
Pradeep Kumar Muniasamy ◽  
Dharanya Gopalakrishnan Srinivasan ◽  
Prabu Velayutham ◽  
Nishanth Savery ◽  
Balasubramanian Krishnaswami ◽  
...  

<p class="abstract"><strong>Background:</strong> Type 1 tympanoplasty is the reconstruction of perforated tympanic membrane with an intact and mobile ossicular chain. Among various autologous graft materials, temporalis fascia and tragal chondroperichondrium are commonly used, having their own merits and demerits. In our study, we have compared the results and postoperative outcomes of tympanoplasty using temporalis fascia and tragal chondroperichondrium.</p><p class="abstract"><strong>Methods:</strong> This prospective comparative study included 60 cases of chronic suppurative otitis media - tubotympanic disease (CSOM-TTD) in a tertiary care centre. They were randomised into two groups of 30 patients each and were subjected to tympanoplasty using either tragal cartilage-perichondrium (group 1) or temporalis fascia graft (group 2) from November 2017 to May 2019. Objective hearing improvement at 1st, 3rd and 6th month postoperative follow-up and graft uptake rate at 3rd month were compared.  </p><p class="abstract"><strong>Results:</strong> Incidence of cases was more in the age group between 31-45 years age group (53.3%). Graft uptake rate was 96.6% for temporalis fascia group and 83.33% for tragal group (p value - 0.194). Preoperative air-bone (AB) gap in group 1 was found to be 25±4.09 dB which improved to 11.73±2.21 dB at 6 months and in group 2, it was 25.7±3.94 dB which improved to 14.06±3.68 dB at 6 months. Mean improvement in hearing for tragal group (13.27 dB) was better than temporalis fascia group (11.64 dB) (p value &lt;0.001).</p><p class="abstract"><strong>Conclusions:</strong> Both temporalis fascia and tragal chondroperichondrium are suitable graft materials for tympanoplasty, although graft uptake was clinically better with the use of temporalis fascia.</p><p> </p>


2020 ◽  
Vol 20 (4) ◽  
pp. 209-215
Author(s):  
A.V. Kuroyedov ◽  
◽  
O.V. Gapon’ko ◽  
V.V. Gorodnichiy ◽  
I.V. Kondrakova ◽  
...  

Aim: to assess the effectiveness and tolerability of anti-VEGF agents, aflibercept (2.0 mg) and ranibizumab (0.5 mg), in the combined treat-ment for wet age-related macular degeneration (AMD) in routine clinical practice.Patients and Methods: 55 patients (65 eyes) with the late stage of wet AMD were divided into two groups. Group 1 included 32 eyes with classic choroidal neovascularization (CNV) and group 2 included 33 eyes with occult CNV. Best-corrected visual acuity (BCVA), intraocular pressure, and retinal nerve fiber layer (RNFL) thickness were measured. These parameters were compared at different time points during the treatment.Results: overall AMD duration (January 2019) was 36 (19; 47) months being 30 (12; 44) months in group 1 and 36 (23; 48) months in group 2 (р>0.05). The first intravitreal administration of an anti-VEGF drug was performed 7.5 (3.5; 9.5) months after AMD diagnosis in group 1 and 7 (3; 11) months after AMD diagnosis in group 2. Significant differences in intragroup intervals were revealed between various follow-up periods. More differences were identified for the intervals between intravitreal administrations in group 2. Baseline and final BCVA during the entire follow-up which was 29.5 (19.5; 38) months in group 1 and 28 (25; 44) months in group 2 demonstrated neither intragroup nor intergroup differences (р>0.05). Conclusion: our management strategy for wet AMD is somewhat different from conventional guidelines. However, it has no significant impact on visual acuity during the follow-up.Keywords: age-related macular degeneration, anti-VEGF drugs, intravitreal administration, IOP level, aflibercept, ranibizumab.For citation: Kuroyedov A.V., Gapon’ko O.V., Gorodnichiy V.V. et al. Effectiveness and tolerability of the combined use of anti-VEGF agents in clinical practice. Russian Journal of Clinical Ophthalmology. 2020;20(4):209–215. DOI: 10.32364/2311-7729-2020-20-4-209-215.


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